[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606572":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":38,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":32,"enrollmentInfo":77,"targetDuration":32,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational Treatment Group (Single Arm)","EXPERIMENTAL","All children with sickle cell anemia who are started on hydroxyurea for clinical indicators between 6 months and 5 years of age can do so on this observational study with PK-optimized hydroxyurea dosing.",[13],"Drug: PK-optimized oral hydroxyurea at MTD until 15 years of age.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","PK-optimized oral hydroxyurea at MTD until 15 years of age.","Because people are different, we will measure how each participant's body absorbs and eliminates the medicine, hydroxyurea, using blood tests. This information will be used to determine the best dose for each participant (rather than using the same weight-based dose for everyone).",[9],[21,22],"pharmacokinetic","maximum tolerated dose",[24],{"name":25,"affiliation":5,"role":26},"Charles T. Quinn, Professor of Pediatrics, M.D., M.S.","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Wendi L. Long, Sr. Regulatory Specialist, BS, CCRC","CONTACT","513-803-3064",null,"wendi.long@cchmc.org",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Teresa Latham, Research Director, DrPH","(513) 803-7922","teresa.latham@cchmc.org",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-84.51439,39.12711,{"lat":51,"lon":50},[54,58],{"name":55,"role":30,"phone":56,"phoneExt":32,"email":57},"Charles T. Quinn, M.D., M.S.","513-803-3086","charles.quinn@cchmc.org",{"name":59,"role":30,"phone":32,"phoneExt":60,"email":61},"Megan Metcalf, CRC, III","(513) 803-2606","megan.metcalf@cchmc.org",{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[65],{"name":66,"class":67},"Greater Cincinnati Foundation","UNKNOWN","100606572","phase-4-effectiveness-of-nontraditional-hydroxyurea-algorithms-novel-and-clinical-evaluations-enhance-100606572",false,"NCT07177300","Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)","ENHANCE","Inclusion Criteria:\n\n* Diagnosis of sickle cell anemia (HbSS) or sickle-β0-thalassemia (HbSβ0)\n* Age 6 months at the time of enrollment\n* Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy\n\nExclusion Criteria:\n\n* Current treatment with regularly scheduled blood transfusions\n* Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+)","ALL","6 Months",{"count":78,"type":79},50,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The main reason for this research study is to learn more about hydroxyurea and the treatment of sickle cell anemia (SCA). Hydroxyurea is a medication that has been studied for many years and has been shown to provide benefits for people with SCA.\n\nIn this research study, the investigators hope to learn more about how to improve the dosing and monitoring of hydroxyurea and learn more about the long-term effects of hydroxyurea over time. Hydroxyurea is usually dosed based only on your weight. Our study will use a new way to select a starting dose that is based on how each patient absorbs hydroxyurea.",[85,86],"Sickle Cell Anemia (HbSS)","Sickle-β0-thalassemia (HbSβ0)",[88,89,90,91],"sickle cell anemia","SCD","sickle cell","hydroxyurea","2025-09-09",{"date":94,"type":95},"2025-09-16","ACTUAL",{"date":97,"type":95},"2024-12-19",{"date":99,"type":79},"2028-12",{"name":5,"class":6},1]